LIDOCAINE ointment

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)

Disponibil de la:

Lake Erie Medical DBA Quality Care Products LLC

INN (nume internaţional):

LIDOCAINE

Compoziție:

LIDOCAINE 5 g in 100 g

Calea de administrare:

TOPICAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Rx Only Lidocaine Ointment 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of Lidocaine Ointment 5%.

Rezumat produs:

Lidocaine Ointment USP, 5% is available in 35.44 g (1¼ oz) laminate tubes with a child-resistant cap, and 50.0 g (1 ¾ oz) jar with child-resistant cap. 55700-384-50 Store at controlled room temperature 20°- 25°C (68°- 77°F). Do not permit to freeze. Manufactured for Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Rev. 933:01 4/12

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

LIDOCAINE- LIDOCAINE OINTMENT
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
LIDOCAINE OINTMENT USP, 5%
FOR TOPICAL USE ONLY
RX ONLY
DESCRIPTION
Lidocaine Ointment 5% contains a local anesthetic agent and is
administered topically. See
INDICATIONS AND USAGE for specific uses.
Lidocaine Ointment 5% contains lidocaine, which is chemically
designated as acetamide, 2-
(diethylamino) -_N_-(2,6-dimethylphenyl)-, and has the following
structural formula:
C H N O M.W. 234.34
Composition of Lidocaine Ointment 5%: acetamide,
2-(diethylamino)-_N_-(2,6-dimethylphenyl)-,
(lidocaine) 5% in a water miscible ointment vehicle containing
polyethylene glycols and peppermint oil.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Lidocaine Ointment 5% effects local, topical anesthesia. The onset of
action is 3-5 minutes. It is
ineffective when applied to intact skin
HEMODYNAMICS
Excessive blood levels may cause changes in cardiac output, total
peripheral resistance, and mean
arterial pressure. These changes may be attributable to a direct
depressant effect of the local anesthetic
agent on various components of the cardiovascular system.
PHARMACOKINETICS AND METABOLISM
Lidocaine may be absorbed following topical administration to mucous
membranes, its rate and extent of
absorption depending upon the specific site of application, duration
of exposure, concentration, and
total dosage. In general, the rate of absorption of local anesthetic
agents following topical application
occurs most rapidly after intratracheal administration. Lidocaine is
also well-absorbed from the
gastrointestinal tract, but little intact drug appears in the
circulation because of biotransformation in the
liver.
Lidocaine is metabolized rapidly by the liver, and metabolites and
unchanged drug are excreted by the
kidneys. Biotransformation includes oxidative N-dealkylation, ring
hydroxylation, cleavage of the amide
linkage, and conjugation. N-dealkylation, a major pathway of
biotransformation, yields the metabolites
monoethylglycinexylidide and glycinexylidide.